Compendial Deferrals for USP41-NF36 2S

Category Monograph Title Monograph Section Scientific Liaison

Revision USP AND NF EXCIPIENTS, LISTED BY CATEGORY PF 42(2) Pg. ONLINE{Emollient} Sodium Lauroyl Sarcosinate, {Emulsifying Agent} Sodium Lauroyl Sarcosinate, {Chaotropic Agent} Hong Wang

New DESCRIPTION AND SOLUBILITY PF 43(1) Pg. ONLINE

Bendamustine Hydrochloride, Climbazole, Ropivacaine, Iscotrizinol, Trientine Hydrochloride, Sodium Lauroyl Sarcosinate, Epinastine Hydrochloride, Carglumic Acid, Desvenlafaxine, Desvenlafaxine Fumarate, Desvenlafaxine Succinate, Gadobutrol, Rotigotine, Benzphetamine Hydrochloride, Deferasirox, Eletriptan Hydrobromide, Milnacipran Hydrochloride, Nebivolol Hydrochloride Feiwen Mao

New PROBIOTIC TESTS PF 43(2) Pg. ONLINE

Title, INTRODUCTION/Introduction, PROCEDURE/Identification, PROCEDURE/Enumeration, PERFORMANCE TESTS/, CONTAMINANTS/Introduction, CONTAMINANTS/Listeria, ADDITIONAL REQUIREMENTS/Storage, ADDITIONAL REQUIREMENTS/Labeling, ??UNKNOWN??/Introduction Seong Jae Yoo

Revision INSULIN ASSAYS PF 43(4) Pg. ONLINE

??UNKNOWN??/Rabbit Blood Sugar Method-Quantitative, ??UNKNOWN??/In Vivo Bioidentity Test, ??UNKNOWN??/In Vitro Cell-Based Bioidentity Test for Insulin Glargine and Insulin Lispro Diane McCarthy

New RESIDUAL DNA TESTING PF 42(5) Pg. ONLINE

Title, INTRODUCTION/Introduction, PROCEDURE/Sample Preparation, PROCEDURE/qPCR Analysis, ADDITIONAL REQUIREMENTS/USP Reference Standards Elena Curti

Revision INHALATION AND NASAL DRUG PRODUCTS- AEROSOLS, SPRAYS, AND POWDERS--PERFORMANCE QUALITY TESTS PF 42(6) Pg. ONLINE

TABLE OF CONTENTS, INTRODUCTION, A. DELIVERED-DOSE UNIFORMITYDELIVERED CONTENT UNIFORMITY, B. DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS, SPRAYS, AND POWDERS DROPLET/PARTICLE SIZE DISTRIBUTION-NASAL AEROSOLS AND SPRAYS, C. AERODYNAMIC PARTICLE SIZE DISTRIBUTION-INHALATION AEROSOLS, SPRAYS, AND POWDERS Kahkashan Zaidi

New CHROMATOGRAPHY PF 43(5) Pg. ONLINEDEFINITIONS, SYSTEM SUITABILITY, ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS, QUANTIFICATION Horacio Pappa

New VISUAL COMPARISON PF 43(5) Pg. ONLINE Title Edmond Biba

Revision OSMOLALITY AND OSMOLARITY PF 43(5) Pg. ONLINEINTRODUCTION, OSMOTIC PRESSUREBACKGROUND, OSMOLALITYOPERATION AND CALIBRATION OF OSMOMETER, OSMOLARITY, MEASUREMENT OF OSMOLALITY Margareth Marques

Revision NEPHELOMETRY, TURBIDIMETRY, AND VISUAL COMPARISON PF 43(5) Pg. ONLINE

Title, Introduction, APPARATUS, PROCEDURE, 1. INTRODUCTION, 2. TERMS AND DEFINITIONS, 3. APPLICATIONS, 4. INSTRUMENTATION, 5. FORMAZIN TURBIDITY STANDARDS, 6. QUALIFICATION OF TURBIDIMETERS AND NEPHELOMETERS, 7. PROCEDURES, 8. VALIDATION AND VERIFICATION Edmond Biba

New NEAR-INFRARED SPECTROSCOPY PF 43(4) Pg. ONLINE

1. INTRODUCTION, 2. QUALIFICATION OF NIR SPECTROMETERS, 3. PROCEDURE, 4. VALIDATION AND VERIFICATION, 1. INTRODUCTION, USP REFERENCE STANDARDS Kahkashan Zaidi

Revision ULTRAVIOLET-VISIBLE SPECTROSCOPY PF 43(5) Pg. ONLINEINTRODUCTION, QUALIFICATION OF UV-VIS SPECTROMETERS, PROCEDURE, VALIDATION AND VERIFICATIONVERIFICATION AND VALIDATION Margareth Marques

New RAMAN SPECTROSCOPY PF 43(4) Pg. ONLINETitle, Introduction, QUALIFICATION OF RAMAN SPECTROMETERS, PROCEDURE, VALIDATION AND VERIFICATION, VERIFICATION, Title Kahkashan Zaidi

Revision SUTURES--NEEDLE ATTACHMENT PF 43(4) Pg. ONLINE Introduction, PROCEDURE Desmond HuntRevision TENSILE STRENGTH PF 43(4) Pg. ONLINE Introduction, SURGICAL SUTURE, TEXTILE FABRICS AND FILMS Desmond Hunt

New MEASUREMENT OF STRUCTURAL STRENGTH OF SEMISOLIDS BY PENETROMETRY PF 43(2) Pg. ONLINE Title, INTRODUCTION, PROCEDURE, GLOSSARY Antonio Hernandez-Cardoso

Revision ANCILLARY MATERIALS FOR CELL, GENE AND TISSUE ENGINEERED PRODUCTS PF 43(4) Pg. ONLINE

INTRODUCTION, REGULATORY CONSIDERATIONS, IMPACT OF ANCILLARY MATERIAL QUALITY ON PRODUCT QUALITY, QUALIFICATION OF ANCILLARY MATERIALS, RISK CLASSIFICATIONMANAGEMENT, PERFORMANCE TESTING, ANCILLARY MATERIALS RESIDUAL LEVELRESIDUAL ASSESSMENT AND REMOVAL, CONCLUSION, APPENDIX Fouad Atouf

Revision ASSESSMENT OF DRUG PRODUCT PERFORMANCE--BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION PF 42(4) Pg. ONLINE

BACKGROUND, BIOAVAILABILITY, BIOEQUIVALENCE, AND DISSOLUTION, BIOEQUIVALENCE, DISSOLUTION AND IN VITRO PRODUCT PERFORMANCE, BIOWAIVER, APPENDIX William Brown

Revision NEAR-INFRARED SPECTROSCOPY PF 43(4) Pg. ONLINE

1. THEORY, 2. TRANSMISSION, REFLECTION, AND TRANSFLECTION MODES, 3. FACTORS THAT AFFECT NIR SPECTRA, 4. PRETREATMENT OF NIR SPECTRAL DATA, 5. INSTRUMENTATION, 6. APPLICATIONS, INTRODUCTION, INSTRUMENTATION, METHOD VALIDATION, GLOSSARY, *No Head*, 1. THEORY, 7. PROCEDURE VALIDATION, 8. APPENDIX: GLOSSARY Kahkashan Zaidi

Revision RAMAN SPECTROSCOPY - THEORY AND PRACTICE PF 40(6) Pg. ONLINE

Title, Introduction, INTRODUCTION, THEORY, QUALITATIVE AND QUANTITATIVE RAMAN MEASUREMENTS, FACTORS AFFECTING QUANTIFICATION, SAMPLING FACTORS, APPARATUS, QUALIFICATION AND VERIFICATION OF RAMAN SPECTROMETERS, SPECIALIZED TECHNIQUES, METHOD VALIDATION, PROCEDURE VALIDATION, DEFINITION OF TERMS AND SYMBOLS, CALIBRATION, FACTORS THAT AFFECT MEASUREMENT PERFORMANCE Kahkashan Zaidi

New MEASUREMENT OF HARDNESS OF SEMISOLIDS PF 43(2) Pg. ONLINE Title, BACKGROUND, EXPERIMENTAL METHODS, GLOSSARY, REFERENCES Antonio Hernandez-Cardoso

New ACARBOSE TABLETS PF 43(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption , ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, IMPURITIES/Microbial Enumeration Tests and Tests for Specified Microorganisms , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Acarbose RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Acarbose System Suitability Mixture RS Kamalpreet Arora

Revision ACETAMINOPHEN TABLETS PF 42(3) Pg. ONLINEIDENTIFICATION/B. Thin-Layer Chromatographic Identification Test , IDENTIFICATION/B., ASSAY/Procedure Clydewyn Anthony

Revision ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS PF 43(5) Pg. ONLINE

IMPURITIES/4-Aminophenol in Acetaminophen-Containing Drug Products , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Codeine N-Oxide RS Wei Yang

Revision ACETAZOLAMIDE PF 43(4) Pg. ONLINEIMPURITIES/Silver-Reducing Substances, IMPURITIES/Ordinary Impurities , IMPURITIES/Organic Impurities Feiwen Mao

Revision ACETAZOLAMIDE TABLETS PF 42(6) Pg. ONLINE

ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Acetazolamide Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Acetazolamide Related Compound E RS Ramanujam Prasad

Revision ALBUMIN HUMAN PF 41(6) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Immunodiffusion, IDENTIFICATION/B. Protein Composition by Zone Electrophoresis, ASSAY/Procedure, OTHER COMPONENTS/Content of Sodium Caprylate, OTHER COMPONENTS/Content of N-Acetyl-dl-tryptophan, IMPURITIES/Prekallikrein Activator , SPECIFIC TESTS/Bacterial Endotoxins Test , SPECIFIC TESTS/Biological Reactivity tests , In Vivo, Safety Tests-Biologicals, SPECIFIC TESTS/Sterility Tests , SPECIFIC TESTS/pH , SPECIFIC TESTS/Molecular Weight Distribution, SPECIFIC TESTS/Heat Stability, SPECIFIC TESTS/Content of Sodium, SPECIFIC TESTS/Limit of Potassium, ADDITIONAL REQUIREMENTS/USP Reference Standards Kevin Carrick

Revision ALCLOMETASONE DIPROPIONATE CREAM PF 43(1) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone Dipropionate RS Mary Koleck

Revision ALCLOMETASONE DIPROPIONATE OINTMENT PF 43(1) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Alclometasone Dipropionate Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone Dipropionate RS Mary Koleck

New ALOSETRON HYDROCHLORIDE PF 43(2) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C17H18N4O·HCl, Chemical Info/330.82, Chemical Info/1H-Pyrido[4,3-b]indol-1-one, 2,3,4,5-tetrahydro-5-methyl-2-[(5-methyl-1H-imidazol-4-yl)methyl]-, hydrochloride;, Chemical Info/2,3,4,5-Tetrahydro-5-methyl-2-[(5-methylimidazol-4-yl)methyl]-1H-pyrido[4,3-b]indol-1-one hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General , Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination , Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Alosetron Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Alosetron Related Compound A RS Andrea Carney

New ALOSETRON TABLETS PF 43(2) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption , IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Alosetron Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Alosetron Related Compound A RS Andrea Carney

Revision AMANTADINE HYDROCHLORIDE PF 43(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/, IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General , Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Clarity and Color of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Amantadine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Amantadine Related Compound B RS Shankari Shivaprasad

Revision AMANTADINE HYDROCHLORIDE CAPSULES PF 43(4) Pg. ONLINE

IDENTIFICATION/A.Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards / Shankari Shivaprasad

Revision AMANTADINE HYDROCHLORIDE ORAL SOLUTION PF 43(4) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Amantadine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Amantadine Related Compound B RS Shankari Shivaprasad

Revision AMINOBENZOIC ACID GEL PF 43(2) Pg. ONLINEIDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/A., ASSAY/Procedure Sujatha Ramakrishna

Revision AMOXICILLIN FOR ORAL SUSPENSION PF 42(6) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Amoxicillin Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Amoxicillin Related Compound H RS Ramanujam Prasad

New ANNATTO SEED TOCOTRIENOLS EXTRACT PF 42(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Procedure, SPECIFIC TESTS/Fats and Fixed Oils , Peroxide Value, SPECIFIC TESTS/Water Determination , Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Annatto Seed Tocotrienols Extract RS Huy Dinh

Revision ASPIRIN PF 41(6) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption or , ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Readily Carbonizable Substances Test , SPECIFIC TESTS/Substances Insoluble in Sodium Carbonate TS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Salicylic Acid RS Clydewyn Anthony

Revision ATROPINE PF 43(1) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Foreign Alkaloids and Other Impurities, IMPURITIES/Readily Carbonizable Substances Test , SPECIFIC TESTS/Melting Range or Temperature , ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Atropine RS Heather Joyce

New AZACITIDINE PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C8H12N4O5, Chemical Info/244.20, Chemical Info/1,3,5-Triazin-2(1H)-one, 4-amino-1-β-d-ribofuranosyl-;, Chemical Info/4-Amino-1-β-d-ribofuranosyl-s-triazin-2(1H)-one, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, IMPURITIES/Limit of 1-β-d-Ribofuranosyl-3-guanylurea, SPECIFIC TESTS/Microbial Enumeration Tests and Tests for Specified Microorganisms , SPECIFIC TESTS/Bacterial Endotoxins Test , SPECIFIC TESTS/Water Determination , Method I, Method Ic, SPECIFIC TESTS/Optical Rotation , Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Azacitidine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Azacitidine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Azacitidine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Azacitidine Related Compound C RS Feiwen Mao

Revision AZATHIOPRINE TABLETS PF 43(3) Pg. ONLINE

IDENTIFICATION/Thin-Layer Chromatographic Identification Test , IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Azathioprine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Mercaptopurine RS Feiwen Mao

New AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION PF 43(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH , SPECIFIC TESTS/Osmolality and Osmolarity , SPECIFIC TESTS/Sterility Tests , SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Azelastine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Azelastine Related Compound F RS Mary Koleck

Revision AZITHROMYCIN PF 43(3) Pg. ONLINE

IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/, Procedure 2, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP N-Demethylazithromycin RS (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-l-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-methylamino-β-d-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. C37H70N2O12 734.96 Praveen Pabba

Revision AZITHROMYCIN FOR ORAL SUSPENSION PF 43(4) Pg. ONLINE

ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Azaerythromycin A RS 9-Deoxo-9a-aza-9a-homoerythromycin A; 6-Demethylazithromycin. C37H70N2O12 734.96, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Azithromycin Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Desosaminylazithromycin RS Praveen Pabba

New BENZPHETAMINE HYDROCHLORIDE PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C17H21N·HCl, Chemical Info/275.82, Chemical Info/(+)-N-Benzyl-N,α-dimethylphenethylamine hydrochloride;, Chemical Info/(S)-N-Benzyl-N-methyl-1-phenylpropan-2-amine hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General , Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, IMPURITIES/Limit of Benzyl Chloride, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Loss on Drying , SPECIFIC TESTS/pH , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzphetamine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzphetamine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzphetamine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzphetamine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzyl Chloride RS Wei Yang

New BENZPHETAMINE HYDROCHLORIDE TABLETS PF 43(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzphetamine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzphetamine Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Methamphetamine Hydrochloride RS Wei Yang

Revision BETAHISTINE HYDROCHLORIDE PF 43(5) Pg. ONLINE

IDENTIFICATION/, IDENTIFICATION/C. Identification Tests-General , Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Organic Impurities Edith Chang

Revision BETAMETHASONE ACETATE PF 42(5) Pg. ONLINE

IDENTIFICATION/Infrared Absorption , IDENTIFICATION/Thin-Layer Chromatographic Identification Test , ASSAY/Procedure, IMPURITIES/Ordinary Impurities , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone Acetate Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone Acetate Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Dexamethasone Acetate RS Mary Koleck

Revision BETAMETHASONE DIPROPIONATE CREAM PF 42(6) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test , IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone Dipropionate Related Compound C RS Mary Koleck

Revision BETAMETHASONE DIPROPIONATE LOTION PF 42(6) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test , IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone Dipropionate Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone Dipropionate Related Compound C RS Mary Koleck

New BUDESONIDE DELAYED-RELEASE CAPSULES PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Budesonide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Budesonide Related Compound E RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Budesonide Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Budesonide Related Compound L RS Mary Koleck

New CALCIUM ACETATE CAPSULES PF 43(2) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Identification Tests-General , Acetate, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , SPECIFIC TESTS/Microbial Enumeration Tests and Tests for Specified Microorganisms , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Calcium Acetate RS Michael Chang

Revision CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLETS PF 43(4) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Limit of Captopril Disulfide, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Captopril Disulfide RS Edith Chang

New CARGLUMIC ACID PF 41(6) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C6H10N2O5, Chemical Info/190.15, Chemical Info/l-Glutamic acid, N-(aminocarbonyl)-;, Chemical Info/N-Carbamoyl-l-glutamic acid, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, IMPURITIES/Limit of d-Carglumic acid, SPECIFIC TESTS/Loss on Drying , SPECIFIC TESTS/Optical Rotation , Procedures, Specific Rotation, SPECIFIC TESTS/pH , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Carglumic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP d-Carglumic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Carglumic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Carglumic Acid Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Carglumic Acid Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP l-Glutamic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Pyroglutamic Acid RS Sujatha Ramakrishna

New CELECOXIB CAPSULES PF 43(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests and Tests for Specified Microorganisms , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Celecoxib RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Celecoxib Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Celecoxib Related Compound C RS Wei Yang

New CHELATING ION EXCHANGE RESIN PF 41(3) Pg. ONLINE Chelating Ion-Exchange Resin Trish LiNew CHLOROMETHYLNITROIMIDAZOLE PF 43(3) Pg. ONLINE Chloromethylnitroimidazole Sridevi Ramachandran

New CHLOROTHIAZIDE COMPOUNDED ORAL SUSPENSION PF 43(5) Pg. ONLINE

Title, DEFINITION/Introduction, ASSAY/Procedure, SPECIFIC TESTS/pH , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Chlorothiazide RS Jeanne Sun

Revision CHLORZOXAZONE PF 43(4) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/Ultraviolet Absorption , ASSAY/Procedure, OTHER COMPONENTS/Chlorine Content, IMPURITIES/Chromatographic Purity, IMPURITIES/Limit of Chlorzoxazone Related Compound A, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature Heather Joyce

Revision CHLORZOXAZONE TABLETS PF 43(4) Pg. ONLINE

IDENTIFICATION/A. Ultraviolet Absorption, IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Limit of Chlorzoxazone Related Compound A, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Chlorzoxazone Related Compound A RS Heather Joyce

New CHOLINE FENOFIBRATE PF 42(6) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C22H28ClNO5, Chemical Info/421.91, Chemical Info/Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, salt with 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (1:1);, Chemical Info/2-Hydroxy-N,N,N-trimethylethanaminium 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination , Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Choline Chloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Choline Fenofibrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Fenofibrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Fenofibric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Fenofibrate Related Compound C RS Sujatha Ramakrishna

New CITICOLINE SODIUM PF 42(6) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C14H25N4NaO11P2, Chemical Info/510.31, Chemical Info/Cytidine 5\'-(trihydrogen diphosphate), P\'-[2-(trimethylammonio)ethyl] ester, inner salt, monosodium salt;, Chemical Info/CDP-choline (sodium), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Chloride and Sulfate , Chloride, IMPURITIES/Related Compounds, SPECIFIC TESTS/Water Determination , Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Citicoline Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP 5′-Cytidylic Acid RS Huy Dinh

New CLIMBAZOLE PF 43(4) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C15H17ClN2O2, Chemical Info/292.76, Chemical Info/1-(p-Chlorophenoxy)-1-imidazol-1-yl-3,3-dimethyl-2-butanone, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Climbazole RS Sujatha Ramakrishna

Revision CLOMIPHENE CITRATE TABLETS PF 43(4) Pg. ONLINE

IDENTIFICATION/Identification-Organic Nitrogenous Bases , IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Mary Koleck

Revision CLOMIPRAMINE HYDROCHLORIDE PF 42(3) Pg. ONLINE

IDENTIFICATION/B. Ultraviolet Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Heavy Metals, Method II , IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Clomipramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Clomipramine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Clomipramine Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Clomipramine Related Compound F RS Heather Joyce

Revision CLOMIPRAMINE HYDROCHLORIDE CAPSULES PF 42(3) Pg. ONLINE

IDENTIFICATION/Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Clomipramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Clomipramine Related Compound C RS Heather Joyce

Revision CYCLOPHOSPHAMIDE FOR INJECTION PF 43(1) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test , IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities: Procedure for the Sterile Powder Formulation, IMPURITIES/Organic Impurities: Procedure for the Lyophilized Formulation, IMPURITIES/Limit of Cyclophosphamide Related Compound C: Procedure for the Lyophilized Formulation, SPECIFIC TESTS/Limit of Chloride for the Lyophilized Formulation, SPECIFIC TESTS/pH , SPECIFIC TESTS/Water Determination , Method I, SPECIFIC TESTS/Bacterial Endotoxins Test , ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Cyclophosphamide Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Cyclophosphamide Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Cyclophosphamide Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Cyclophosphamide Related Compound D RS Feiwen Mao

Revision CYPROHEPTADINE HYDROCHLORIDE TABLETS PF 43(1) Pg. ONLINE IMPURITIES/Organic Impurities Mary Koleck

New DEFERASIROX PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C21H15N3O4, Chemical Info/373.36, Chemical Info/Benzoic acid, 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-;, Chemical Info/4-[3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination , Method I, Method Ia, SPECIFIC TESTS/Microbial Enumeration Tests and Tests for Specified Microorganisms , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Deferasirox RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Deferasirox System Suitability Mixture RS Andrea Carney

New DESVENLAFAXINE PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C16H25NO2, Chemical Info/263.38, Chemical Info/4-[2-(Dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol;, Chemical Info/1-[2-(Dimethylamino)-1-(4-hydroxyphenyl)ethyl]cyclohexanol hydrogen, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Desvenlafaxine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Desvenlafaxine Related Compound A RS 4-[1-(Cyclohex-1-en-1-yl)-2-(dimethylamino)ethyl]phenol.C16H23NO245.37, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Venlafaxine Hydrochloride RS Heather Joyce

New DESVENLAFAXINE FUMARATE PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C16H25NO2·C4H4O4·H2O, Chemical Info/397.46, Chemical Info/C16H25NO2·C4H4O4, Chemical Info/379.45, Chemical Info/trans-Butenedioic acid, compound with 4-[2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol (1:1), monohydrate;, Chemical Info/1-[2-(Dimethylamino)-1-(4-hydroxyphenyl)ethyl]cyclohexanol trans-butenedioate monohydrate, Chemical Info/CAS, Chemical Info/Anhydrous, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation , Procedures, Specific Rotation, SPECIFIC TESTS/pH , SPECIFIC TESTS/Water Determination , Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Desvenlafaxine Fumarate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Desvenlafaxine Related Compound B RS 4-[1-(1-Hydroxycyclohexyl)-2-(methylamino)ethyl]phenol.C15H23NO2249.35 Heather Joyce

New DESVENLAFAXINE SUCCINATE PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C16H25NO2·C4H6O4·H2O, Chemical Info/399.48, Chemical Info/C16H25NO2·C4H6O4, Chemical Info/381.47, Chemical Info/ Butanedioic acid, compound with 4-[2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol (1:1), monohydrate;, Chemical Info/ 1-[2-(Dimethylamino)-1-(4-hydroxyphenyl)ethyl]cyclohexanol hydrogen butanedioate monohydrate, Chemical Info/CAS, Chemical Info/Anhydrous, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation , Procedures, Specific Rotation, SPECIFIC TESTS/Water Determination , Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Desvenlafaxine Succinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Desvenlafaxine Related Compound B RS 4-[1-(1-Hydroxycyclohexyl)-2-(methylamino)ethyl]phenol.C15H23NO2249.35 Heather Joyce

Revision DEXAMETHASONE PF 42(4) Pg. ONLINE

IDENTIFICATION/Infrared Absorption , IDENTIFICATION/B. Ultraviolet Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Desoximetasone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Dexamethasone Acetate RS Mary Koleck

Revision DEXAMETHASONE OPHTHALMIC SUSPENSION PF 43(3) Pg. ONLINE

IDENTIFICATION/Thin-Layer Chromatography, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone RS Mary Koleck

Revision DEXAMETHASONE SODIUM PHOSPHATE INJECTION PF 43(3) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatography, IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Betamethasone Sodium Phosphate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Endotoxin RS Mary Koleck

Revision DEXTROMETHORPHAN PF 43(5) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , ASSAY/Procedure, IMPURITIES/Limit of Phenolic Compounds, IMPURITIES/Limit of N,N-Dimethylaniline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Dextromethorphan Related Compound C RS Clydewyn Anthony

Revision DEXTROMETHORPHAN HYDROBROMIDE PF 43(5) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption , ASSAY/Procedure, IMPURITIES/Limit of Phenolic Compounds, IMPURITIES/Limit of N,N-Dimethylaniline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Dextromethorphan Related Compound C RS Clydewyn Anthony

Revision DIHYDROCODEINE BITARTRATE PF 43(3) Pg. ONLINE

Chemical Info/4,5α-Epoxy-3-methoxy-17-methylmorphinan-6α-ol (+)-tartrate (salt)5965-13-9, Chemical Info/Chemical Name Dihydrocodeine (free base)C18H23NO3301.39 125-28-0 Chemical Info/CAS, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Ordinary Impurities , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Ammonium Salts, SPECIFIC TESTS/Melting Range or Temperature , Class I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Codeine Sulfate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Morphine Sulfate RS Wei Yang

Revision DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES PF 43(5) Pg. ONLINE PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities Clydewyn Anthony

Revision DIPHENHYDRAMINE HYDROCHLORIDE ORAL SOLUTION PF 43(5) Pg. ONLINE

IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Diphenhydramine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Diphenhydramine N-Oxide RS Clydewyn Anthony

New DIPHENHYDRAMINE HYDROCHLORIDE TABLETS PF 43(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , Procedure, Apparatus 1 and Apparatus 2, Immediate-Release Dosage Forms, Procedure for a Pooled Sample, PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Diphenhydramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Diphenhydramine N-Oxide RS Clydewyn Anthony

RevisionDIPHENHYDRAMINE AND PHENYLEPHRINE HYDROCHLORIDES TABLETS PF 43(5) Pg. ONLINE ASSAY/Procedure, IMPURITIES/Organic Impurities Clydewyn Anthony

New DIPHENHYDRAMINE HYDROCHLORIDE ORAL POWDER PF 43(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzhydrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzophenone RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Diphenhydramine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Diphenhydramine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Diphenhydramine N-Oxide RS Clydewyn Anthony

New DONG QUAI ROOT PF 43(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin , IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin , Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin , Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin , Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests , CONTAMINANTS/Absence of Specified Microorganisms , Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Alcohol-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Volatile Oil Determination, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination , Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Angelica sinensis Root Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Z-Ligustilide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Senkyunolide A RS Cuiying Ma

New DONG QUAI ROOT POWDER PF 43(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin , IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin , Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin , Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin , Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests , CONTAMINANTS/Absence of Specified Microorganisms , Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Alcohol-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Volatile Oil Determination, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination , Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Angelica sinensis Root Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Z-Ligustilide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Senkyunolide A RS Cuiying Ma

Revision DOXYLAMINE SUCCINATE PF 42(3) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/B. Identification-Organic Nitrogenous Bases , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Volatile Related Compounds, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature, Class I , ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Carbinoxamine Related Compound C RS Richard Nguyen

Revision DOXYLAMINE SUCCINATE TABLETS PF 42(3) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Carbinoxamine Related Compound C RS Richard Nguyen

New ELETRIPTAN HYDROBROMIDE PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C22H26N2O2S·HBr, Chemical Info/463.43, Chemical Info/C22H26N2O2S·HBr·H2O, Chemical Info/481.45, Chemical Info/(R)-3-[(1-Methyl-2-pyrrolidinyl)methyl]-5-[2-(phenylsulfonyl)ethyl]-1H-indole monohydrobromide;, Chemical Info/3-{[(R)-1-Methyl-2-pyrrolidinyl]methyl}-5-[2-(phenylsulfonyl)ethyl]indole, monohydrobromide, Chemical Info/CAS, Chemical Info/Monohydrate, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General , Chemical Identification Tests, Bromide, ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Limit of Eletriptan S-Enantiomer, IMPURITIES/Limit of Isopropyl p-Toluenesulfonate (if present), IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2, SPECIFIC TESTS/Water Determination , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Eletriptan Hydrobromide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Eletriptan Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Eletriptan S-Enantiomer RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Isopropyl p-Toluenesulfonate RS Heather Joyce

Revision EPHEDRINE PF 43(5) Pg. ONLINE

IDENTIFICATION/A.Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation , ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Pseudoephedrine Sulfate RS Clydewyn Anthony

Revision EPHEDRINE SULFATE PF 43(5) Pg. ONLINE

Chemical Info/Chemical Structure, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Ordinary Impurities , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation , ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Pseudoephedrine Sulfate RS Clydewyn Anthony

New EPINASTINE HYDROCHLORIDE PF 43(2) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C16H15N3·HCl, Chemical Info/285.78, Chemical Info/1H-Dibenzo[c,f]imidazo[1,5-a]azepin-3-amine, 9,13b-dihydro-, hydrochloride;, Chemical Info/3-Amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General , Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH , SPECIFIC TESTS/Water Determination , Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Epinastine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Epinastine Related Compound A RS Gerald Hsu

Revision EPINEPHRINE PF 42(6) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Limit of Adrenalone, IMPURITIES/Limit of Norepinephrine, IMPURITIES/Enantiomeric Purity, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation, Specific Rotation , SPECIFIC TESTS/Loss on Drying , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Adrenalone Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Epinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Epinephrine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Norepinephrine Bitartrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Racepinephrine Hydrochloride RS Sujatha Ramakrishna

Revision EPINEPHRINE INJECTION PF 43(3) Pg. ONLINE

IDENTIFICATION/A., ASSAY/Procedure, IMPURITIES/Enantiomeric Purity, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Racepinephrine Hydrochloride RS Gerald Hsu

New EPTACOG ALFA ACTIVATED PF 41(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C1982H3054N560O618S28, Chemical Info/INS: (The chemical formula includes the γ-carboxylations and modification of D (Asp) in position 63, and does not include the glycosylations.), Chemical Info/≊50,000 (The molecular weight includes the glycosylation.), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B. Peptide Mapping, ASSAY/Concentration of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Gla-Domainless Eptacog Alfa (γ-Carboxylation), IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, IMPURITIES/Non-Activated Factor VII (Single Chain), SPECIFIC TESTS/Glycan Analysis, SPECIFIC TESTS/Bacterial Endotoxins Test , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Coagulation Factor VIIa for Bioassay RS, {Title} Activated, ASSAY/Concentration of Eptacog Alfa Activated, IMPURITIES/Gla-Domainless Eptacog Alfa Activated (γ-Carboxylation) Kevin Carrick

New EPTACOG ALFA ACTIVATED FOR INJECTION PF 41(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., ASSAY/Content of Eptacog Alfa, ASSAY/Potency, IMPURITIES/Degraded Heavy Chain and Oxidized Forms, IMPURITIES/Dimer and Related Substances of Higher Molecular Mass, SPECIFIC TESTS/Water Determination , Method 1c, SPECIFIC TESTS/Bacterial Endotoxins Test , SPECIFIC TESTS/pH , SPECIFIC TESTS/Sterility Tests , Test for Sterility of the Product to Be Examined, Membrane Filtration, SPECIFIC TESTS/Constituted Solution, ADDITIONAL REQUIREMENTS/Packaging and Storage Requirements , Injection Packaging, Sterile solids packaging, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Coagulation Factor VIIa RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Coagulation Factor VIIa for Bioassay RS, {Title} Activated, ASSAY/Content of Eptacog Alfa Activated Kevin Carrick

Revision Eriochrome Black T PF 43(5) Pg. ONLINE Eriochrome Black T Margareth Marques

Revision ESTRIOL PF 43(3) Pg. ONLINE

IDENTIFICATION/Ultraviolet Absorption , ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Completeness of Solution, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Estradiol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Estriol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Estrone RS Gerald Hsu

New ESTRIOL COMPOUNDED VAGINAL CREAM PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Beyond-Use Date, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Estriol RS Jeanne Sun

Omission ETHOTOIN PF 43(3) Pg. ONLINE Entire document Heather JoyceOmission ETHOTOIN TABLETS PF 43(3) Pg. ONLINE Entire document Heather Joyce

New EVEROLIMUS PF 42(6) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C53H83NO14, Chemical Info/958.22, Chemical Info/(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone;, Chemical Info/(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-Hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Limit of Alcohol, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Sirolimus, SPECIFIC TESTS/Water Determination , Method I, SPECIFIC TESTS/Optical Rotation , Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests and Tests for Specified Organisms , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Everolimus RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Everolimus System Suitability Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Sirolimus RS Morgan Puderbaugh

New FENOFIBRIC ACID DELAYED-RELEASE CAPSULES PF 42(6) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Fenofibric Acid RS Sujatha Ramakrishna

New FLUVASTATIN EXTENDED-RELEASE TABLETS PF 42(4) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Fluvastatin Sodium RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Fluvastatin for System Suitability RS Sujatha Ramakrishna

Revision FLUVOXAMINE MALEATE TABLETS PF 42(5) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Test 2, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling Heather Joyce

Revision FONDAPARINUX SODIUM PF 42(5) Pg. ONLINE

ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination , Method I, Method Ic, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Fondaparinux Sodium System Suitability Mixture B RS Kevin Carrick

Revision FONDAPARINUX SODIUM INJECTION PF 42(5) Pg. ONLINEIDENTIFICATION/B. Identification Tests-General , Chloride, ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Bacterial Endotoxins Test Kevin Carrick

Revision FUMARIC ACID PF 43(5) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Maleic Acid and Malic Acid, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Glacial Acetic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Lactic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Malic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Succinic Acid RS Galina Holloway

New GADOBUTROL PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C18H31GdN4O9·H20, Chemical Info/622.73, Chemical Info/Gadolinium, [10-[2-(hydroxy-&kgr;O)-3-hydroxy-1-(hydroxymethyl)propyl]-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato(3-)-&kgr;N1, &kgr;N4, &kgr;N7, &kgr;N10,&kgr;O1, &kgr;O4, &kgr;O7]-, monohyrdate, [SA-8-1425362′5′-(R*,S*)]-;, Chemical Info/ [10-[(2RS,3SR)-1,2,3-Trihydroxybutan-2-yl]-1,4,7,10-tetraazacyclododecane-1,4,7-triacetato(3-)]gadolinium monohydrate, Chemical Info/CAS, Chemical Info/Anhydrous, Chemical Info/604.71, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Free Gadolinium, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination , Method I, Method Ic, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Gadobutrol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Gadobutrol System Suitability Mixture RS Ravi Ravichandran

Revision GENTAMICIN SULFATE PF 43(3) Pg. ONLINEIDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., IMPURITIES/Organic Impurities, SPECIFIC TESTS/Content of Gentamicins Slavica Shane

Revision GUANABENZ ACETATE TABLETS PF 43(5) Pg. ONLINE DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure Edith Chang

New GUANIDINE HYDROCHLORIDE PF 43(4) Pg. ONLINE

IDENTIFICATION/C. Identification Tests-General , Chemical Identification Tests, Chloride, Title, Chemical Info/Chemical Structure, Chemical Info/CH5N3·HCl, Chemical Info/95.53, Chemical Info/Guanidine, hydrochloride (1:1);, Chemical Info/Guanidine hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption or , IDENTIFICATION/B. Ultraviolet Absorption , ASSAY/Procedure, IMPURITIES/Chloride and Sulfate , Sulfate, IMPURITIES/Limit of Nitrate, IMPURITIES/Limit of Cyanide, IMPURITIES/Residue on Ignition , SPECIFIC TESTS/Acidity, SPECIFIC TESTS/Water-Insoluble Substances, SPECIFIC TESTS/Loss on Drying , SPECIFIC TESTS/Melting Range or Temperature , Procedures, Class 1, SPECIFIC TESTS/Bacterial Endotoxins Test , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Guanidine Hydrochloride RS Galina Holloway

Revision IMIPENEM PF 43(3) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Solvents, SPECIFIC TESTS/Optical Rotation , Procedures, Specific Rotation, SPECIFIC TESTS/Loss on Drying, SPECIFIC TESTS/Water Determination , ADDITIONAL REQUIREMENTS/Packaging and Storage Ramanujam Prasad

New ISCOTRIZINOL PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C44H59N7O5, Chemical Info/765.98, Chemical Info/Benzoic acid, 4,4′-[[6-[[4-[[(1,1-dimethylethyl)amino]carbonyl]phenyl]amino]-1,3,5-triazine-2,4-diyl]diimino]bis-, bis(2-ethylhexyl) ester;, Chemical Info/Bis(2-ethylhexyl) 4,4′-[(6-{[4-(tert-butylcarbamoyl)phenyl]amino}-1,3,5-triazine-2,4-diyl)diimino]dibenzoate, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ethylhexyl Triazone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ethylhexyl Triazone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ethylhexyl Triazone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Iscotrizinol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Iscotrizinol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Iscotrizinol Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Iscotrizinol Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Iscotrizinol Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Iscotrizinol Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Iscotrizinol Related Compound I RS Feiwen Mao

Revision ISOSORBIDE DINITRATE TABLETS PF 42(5) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, Performance Tests/Dissolution Sujatha Ramakrishna

New L-ALPHA-GLYCERYLPHOSPHORYLCHOLINE PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C8H20NO6P, Chemical Info/257.22, Chemical Info/Choline hydroxide, (R)-2,3-dihydroxypropyl hydrogen phosphate, inner salt;, Chemical Info/(R)-2,3-Dihydroxypropyl 2-(trimethylammonio)ethyl phosphate;, Chemical Info/l-α-Glycerylphosphorylcholine, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Chloride, Sulfate, Phosphate, and Acetate, IMPURITIES/Limit of Glycerol, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Optical Rotation , Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests , SPECIFIC TESTS/Absence of Specified Microorganisms , Test Procedures, Test for Absence of Salmonella Species, Test for Absence of Escherichia coli, and Test for Absence of Staphylococcus aureus, SPECIFIC TESTS/pH , SPECIFIC TESTS/Water Determination , Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Glycerin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP l-alpha-Glycerophosphorylethanolamine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP l-alpha-Glycerylphosphorylcholine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP l-alpha-Glycerylphosphorylcholine Solution RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP beta-Glycerylphosphorylcholine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP l-Serine RS Huy Dinh

New L113 PF 43(4) Pg. ONLINE L113- Michael ChangNew L115 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex CarboPac PA100) Trish LiNew L116 PF 41(3) Pg. ONLINE L## (Eptacog Alfa, Dionex DNAPac PA100) Trish Li

New LACTULOSE PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C12H22O11, Chemical Info/342.30, Chemical Info/d-Fructose, 4-O-β-d-galactopyranosyl-;, Chemical Info/4-O-β-d-Galactopyranosyl-d-fructofuranose, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH , SPECIFIC TESTS/Water Determination , Method I, Method Ia, SPECIFIC TESTS/Optical Rotation , Procedures, Specific Rotation, SPECIFIC TESTS/Microbial Enumeration Tests and Tests for Specified Microorganisms , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Epilactose RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Lactose Monohydrate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Lactulose RS Andrea Carney

Revision LEUCOVORIN CALCIUM PF 42(5) Pg. ONLINE

IDENTIFICATION/Infrared Absorption, IDENTIFICATION/B. Identification Tests-General , Calcium, IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Limit of 5-(γ-Folinoyl)tetrahydrofolate, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Folic Acid RS Feiwen Mao

New LEUCOVORIN CALCIUM FOR INJECTION PF 42(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. Ultraviolet Absorption , IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH , SPECIFIC TESTS/Particulate Matter in Injections , SPECIFIC TESTS/Sterility Tests , SPECIFIC TESTS/Bacterial Endotoxins Test , SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Folic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Leucovorin Calcium RS Feiwen Mao

Revision LIDOCAINE HYDROCHLORIDE PF 43(3) Pg. ONLINEIDENTIFICATION/A. Infrared Absorption , ASSAY/Procedure, IMPURITIES/Organic Impurities Richard Nguyen

Revision LIOTHYRONINE SODIUM PF 43(3) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., IDENTIFICATION/C., IDENTIFICATION/D., ASSAY/Procedure, IMPURITIES/Chloride Content, SPECIFIC TESTS/Sodium Content, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Levothyroxine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Liothyronine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Liothyronine Sodium RS Andrea Carney

Revision LOPERAMIDE HYDROCHLORIDE PF 43(4) Pg. ONLINE

Chemical Info/Chemical Name 4-[4-(4-Chlorophenyl)-4-hydroxypiperidin-1-yl]-N,N-dimethyl-2,2-diphenylbutanamide hydrochloride, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B. Ultraviolet Absorption , IDENTIFICATION/B. Identification Tests-General , Chemical Identification Tests, Chloride, ASSAY/Procedure, OTHER COMPONENTS/Chloride, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Loss on Drying , ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Loperamide System Suitability Mixture RS Andrea Carney

Revision MALEIC ACID PF 43(5) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Procedure, IDENTIFICATION/C., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Fumaric Acid and Malic Acid, SPECIFIC TESTS/Color and Clarity of Solution, SPECIFIC TESTS/Water Determination , Method I, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Glacial Acetic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Lactic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Malic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Succinic Acid RS Galina Holloway

Revision MEFENAMIC ACID CAPSULES PF 42(5) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test , IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP 2,3-Dimethylaniline RS Hillary Cai

Revision MEGESTROL ACETATE PF 42(6) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature , ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Medroxyprogesterone Acetate RSUSP Megestrol Acetate Related Compound C RS 6,13aβ-Dimethyl-3,17-dioxo-13(17)a-homoandrosta-4,6-diene-13a-yl acetate.(C24H34O4386.52 ) USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene-17-yl acetate.(C24H32O4384.51 ) USP Megestrol Acetate Related Compound H RS 2α,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4398.54 ) Gerald Hsu

Revision MEGESTROL ACETATE TABLETS PF 42(6) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Medroxyprogesterone Acetate RS USP Megestrol Acetate Related Compound D RS 6-Methylene-3,20-dioxopregn-4-ene-17-yl acetate.(C24H32O4 384.51 )USP Megestrol Acetate Related Compound H RS 2α,6-Dimethyl-3,20-dioxopregna-4,6-dien-17-yl acetate.(C25H34O4 398.54 ) Gerald Hsu

New MESNA INJECTION PF 43(1) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, OTHER COMPONENTS/Content of Benzyl Alcohol (if present), IMPURITIES/Organic Impurities, SPECIFIC TESTS/Sterility Tests , SPECIFIC TESTS/Bacterial Endotoxins Test , SPECIFIC TESTS/Particulate Matter in Injections , SPECIFIC TESTS/pH , SPECIFIC TESTS/Other Requirements, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzaldehyde RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Benzyl Alcohol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Mesna RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Mesna Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Mesna Related Compound B RS Hillary Cai

Revision METHOHEXITAL PF 42(5) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/, IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature Gerald Hsu

Revision METHOHEXITAL SODIUM FOR INJECTION PF 42(5) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities Gerald Hsu

Revision METHOXSALEN PF 43(4) Pg. ONLINE

Chemical Info/Chemical Name 9-Methoxy-7H-furo[3,2-g]chromen-7-one, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature , Class I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Methoxsalen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Methoxsalen Related Compound B RS Feiwen Mao

Revision METHOXSALEN CAPSULES PF 43(4) Pg. ONLINE

IDENTIFICATION/Procedure, ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Methoxsalen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Methoxsalen Related Compound B RS Feiwen Mao

Revision METHOXSALEN TOPICAL SOLUTION PF 43(4) Pg. ONLINEDEFINITION/Introduction, IDENTIFICATION/Procedure, IDENTIFICATION/B., ASSAY/Procedure Feiwen Mao

Revision METOPROLOL TARTRATE INJECTION PF 43(4) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Endotoxin RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Metoprolol Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Metoprolol Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Metoprolol Related Compound C RS Donald Min

Revision MICONAZOLE PF 41(5) Pg. ONLINEADDITIONAL REQUIREMENTS/USP Reference Standards /USP Miconazole Related Compound C RS Clydewyn Anthony

New MILNACIPRAN HYDROCHLORIDE PF 43(3) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C15H22N2O·HCl, Chemical Info/282.81, Chemical Info/Cyclopropanecarboxamide, 2-(aminomethyl)-N,N-diethyl-1-phenyl-, monohydrochloride, (1R,2S)-rel-;, Chemical Info/(1RS,2SR)-2-(Aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride;, Chemical Info/Z-2 Aminomethyl-1-phenyl-N,N-diethylcyclopropanecarboxamide hydrochloride, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., IDENTIFICATION/C. Identification Tests-General , Chemical Identification Tests, Chloride, ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Early Eluting Organic Impurities, IMPURITIES/Late Eluting Organic Impurities, SPECIFIC TESTS/Water Determination , Method I, Method Ic, SPECIFIC TESTS/Optical Rotation , Procedures, Specific Rotation, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Milnacipran Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Milnacipran Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Milnacipran Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Milnacipran Related Compound C RS (1RS,2SR)-2-[(1,3-Dioxoisoindolin-2-yl)methyl]-N,N-diethyl-1-phenylcyclopropane-1-carboxamide.C23H24N2O3376.46 Mary Koleck

New MILNACIPRAN HYDROCHLORIDE TABLETS PF 43(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Milnacipran Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Milnacipran Related Compound A RS (1RS,2SR)-2-(Aminomethyl)-1-phenylcyclopropane-1-carboxylic acid hydrochloride.C11H13NO2·HCl227.69, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Milnacipran Related Compound B RS (1RS,5SR)-1-Phenyl-3-azabicyclo[3.1.0]hexan-2-one.C11H11NO173.21 Mary Koleck

Revision NAPROXEN PF 42(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/Infrared Absorption , IDENTIFICATION/B. Ultraviolet Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation, Specific Rotation , ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound L RS Richard Nguyen

Revision NAPROXEN ORAL SUSPENSION PF 42(4) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound L RS Sujatha Ramakrishna

Revision NAPROXEN DELAYED-RELEASE TABLETS PF 42(4) Pg. ONLINE

IDENTIFICATION/A. Ultraviolet Absorption , IDENTIFICATION/A., ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , Procedure, Apparatus 1 and Apparatus 2, Delayed-Release Dosage Forms, Method B Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound L RS Richard Nguyen

Revision NAPROXEN SODIUM PF 42(4) Pg. ONLINE

IDENTIFICATION/Infrared Absorption , IDENTIFICATION/B. Ultraviolet Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Optical Rotation, Specific Rotation , ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound K RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Naproxen Related Compound L RS Richard Nguyen

Revision NIFEDIPINE CAPSULES PF 43(2) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Donald Min

Revision OLANZAPINE AND FLUOXETINE CAPSULES PF 42(5) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Fluoxetine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Fluoxetine Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Olanzapine RS Gerald Hsu

Revision ORLISTAT CAPSULES PF 43(5) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B. Infrared Absorption , ASSAY/Procedure, PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Orlistat Related Compound D RS Hillary Cai

Revision PAMABROM PF 43(2) Pg. ONLINE

IDENTIFICATION/A. Thin-Layer Chromatographic Identification Test , IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/8-Bromotheophylline, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Pamabrom Related Compound A RS Clydewyn Anthony

Revision PENTAZOCINE HYDROCHLORIDE PF 42(3) Pg. ONLINE

Chemical Info/Chemical Structure, IDENTIFICATION/A. Ultraviolet Absorption , IDENTIFICATION/A., IDENTIFICATION/B. Identification-Organic Nitrogenous Bases , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities , IMPURITIES/Organic Impurities Hillary Cai

Revision PHENTOLAMINE MESYLATE PF 43(3) Pg. ONLINE

IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Phentolamine Amine Analog RS Donald Min

Revision PHENYLEPHRINE HYDROCHLORIDE INJECTION PF 43(5) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Phenylephrine Related Compound F RS Hillary Cai

Revision PHENYLEPHRINE HYDROCHLORIDE TABLETS PF 43(5) Pg. ONLINE

IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Phenylephrine Related Compound F RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Phenylephrine Related Compound G RS Clydewyn Anthony

New POLIDOCANOL PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C30H62O10, Chemical Info/ n = an average of nine (9), Chemical Info/582.8 (based on an average of 9 moieties), Chemical Info/Poly(oxy-1,2-ethanediyl), α-dodecyl-ω-hydroxy-;, Chemical Info/Polyethylene glycol monododecyl ether (average polymer, n = 9; nonaethylene glycol monododecyl ether), Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, ASSAY/Distribution of Oligomers, ASSAY/Average Oligomer Chain Length, IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ethylene Oxide and 1,4-Dioxane, IMPURITIES/Limit of Formaldehyde and Acetaldehyde, IMPURITIES/Limit of Formic Acid and Acetic Acid, SPECIFIC TESTS/Alkalinity, SPECIFIC TESTS/Appearance of Solution, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Total Ash, SPECIFIC TESTS/Fats and Fixed Oils , Procedures, Hydroxyl Value, SPECIFIC TESTS/Fats and Fixed Oils , Procedures, Iodine Value, SPECIFIC TESTS/Fats and Fixed Oils , Procedures, Saponification Value, SPECIFIC TESTS/Water Determination , Method I, SPECIFIC TESTS/Bacterial Endotoxins Test , SPECIFIC TESTS/Microbial Enumeration Tests , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Polidocanol RS Donald Min

Revision PRAZOSIN HYDROCHLORIDE CAPSULES PF 43(5) Pg. ONLINE

IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Prazosin Hydrochloride RS Donald Min

Revision PREDNISONE PF 42(2) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Cortisone RS Ren-Hwa Yeh

RevisionPROMETHAZINE AND PHENYLEPHRINE HYDROCHLORIDE ORAL SOLUTION PF 43(3) Pg. ONLINE

IDENTIFICATION/B., IMPURITIES/Organic Impurities, Procedure 1, IMPURITIES/Organic Impurities, Procedure 2 Sujatha Ramakrishna

Revision PROTRIPTYLINE HYDROCHLORIDE PF 43(4) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B. Ultraviolet Absorption , IDENTIFICATION/B., IDENTIFICATION/D. X-Ray Diffraction , ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/pH Claire Chisolm

Revision PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS PF 43(5) Pg. ONLINEIMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards / USP Benzaldehyde RS USP Benzoic Acid RS Clydewyn Anthony

Revision RESERPINE PF 42(6) Pg. ONLINE

IDENTIFICATION/Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage Donald Min

Revision RESERPINE TABLETS PF 42(6) Pg. ONLINEIDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Other Alkaloids Donald Min

New ROPIVACAINE PF 43(1) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C17H26N2O, Chemical Info/274.40, Chemical Info/(S)-(-)-1-Propylpiperidine-2-carboxylic acid (2,6-dimethylphenyl)-amide;, Chemical Info/(S)-(-)-1-Propyl-2′,6′-pipecoloxylidide, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Organic Impurities, IMPURITIES/Limit of Ropivacaine Related Compound A, IMPURITIES/Enantiomeric Purity, SPECIFIC TESTS/Bacterial Endotoxins Test , SPECIFIC TESTS/Color, SPECIFIC TESTS/Water Determination , Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Bupivacaine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ropivacaine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ropivacaine Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ropivacaine Related Compound B RS Ren-Hwa Yeh

New ROTIGOTINE PF 43(5) Pg. ONLINE

Title, Chemical Info/Chemical Structure, Chemical Info/C19H25NOS, Chemical Info/315.47, Chemical Info/1-Naphthalenol, 5,6,7,8-tetrahydro-6-[propyl [2-(2-thienyl)ethyl]amino-(6S)-;, Chemical Info/(-)-(S)-5,6,7,8-Tetrahydro-6-[propyl[2-(2-thienyl)ethyl]amino]-1-naphthol;, Chemical Info/(6S)-6-[Propyl(2-(2-thienyl)ethyl)amino]-5,6,7,8-tetrahydro-1-naphthalenol, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Residue on Ignition , IMPURITIES/Limit of Rotigotine R-Enantiomer, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Water Determination , Method I, Method Ia, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Rotigotine RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Rotigotine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Rotigotine Related Compound G RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Rotigotine Related Compound H RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Rotigotine Racemate RS Ravi Ravichandran

New ROTIGOTINE TRANSDERMAL SYSTEM PF 43(5) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Drug Release , PERFORMANCE TESTS/Uniformity of Dosage Units , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Rotigotine Hydrochloride RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Rotigotine Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Rotigotine Related Compound K RS Ravi Ravichandran

Revision SALICYLIC ACID PLASTER PF 43(2) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Phenol RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Salicylic Acid Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Salicylic Acid Related Compound B RS Clydewyn Anthony

Revision SELENIUM SULFIDE TOPICAL SUSPENSION PF 43(3) Pg. ONLINEIDENTIFICATION/A., ASSAY/Procedure, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards Michael Chang

New SICHUAN LOVAGE RHIZOME PF 43(4) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin , IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin , Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin , Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin , Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests , CONTAMINANTS/Absence of Specified Microorganisms , Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Foreign Organic Matter, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination , Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ligusticum chuanxiong Rhizome Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Z-Ligustilide RS Cuiying Ma

New SICHUAN LOVAGE RHIZOME POWDER PF 43(4) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A. HPTLC for Articles of Botanical Origin , IDENTIFICATION/B. HPLC, COMPOSITION/Content of Butylidenephthalides and Phenylpropanoids, CONTAMINANTS/Articles of Botanical Origin , Limits of Elemental Impurities, CONTAMINANTS/Articles of Botanical Origin , Pesticide Residue Analysis, CONTAMINANTS/Articles of Botanical Origin , Test for Aflatoxins, CONTAMINANTS/Microbial Enumeration Tests , CONTAMINANTS/Absence of Specified Microorganisms , Test Procedures, Test for Absence of Salmonella Species and Test for Absence of Escherichia coli, SPECIFIC TESTS/Botanical Characteristics, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Alcohol-Soluble Extractives, Method 1, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Water-Soluble Extractives, Method 2, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Total Ash, SPECIFIC TESTS/Articles of Botanical Origin , Methods of Analysis, Acid-Insoluble Ash, SPECIFIC TESTS/Water Determination , Method II, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ferulic Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Ligusticum chuanxiong Rhizome Powder RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Z-Ligustilide RS Cuiying Ma

Revision SODIUM LAUROYL SARCOSINATE PF 43(4) Pg. ONLINE

IMPURITIES/Limit of Sodium Sarcosinate, IMPURITIES/Limit of Sodium Laurate, IMPURITIES/Limit of Sodium Sulfate, Chemical Info/Chemical Structure, Chemical Info/Glycine, N-methyl-N-(1-oxododecyl)-, sodium salt;, Chemical Info/Sodium N-dodecanoyl-N-methylglycinate;, Chemical Info/Sodium N-lauroyl-N-methylglycinate;, Chemical Info/Sodium [dodecanoyl(methyl)amino]acetate, Chemical Info/C15H28NNaO3, Chemical Info/293.38, Chemical Info/CAS, DEFINITION/Introduction, IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B. Chromatographic Identity, IDENTIFICATION/C. Presence of Sodium, ASSAY/Procedure, IMPURITIES/Limit of Sodium Decanoyl Sarcosinate and Sodium Myristoyl Sarcosinate, IMPURITIES/Limit of Sodium Sarcosinate, IMPURITIES/Limit of Sodium Chloride, SPECIFIC TESTS/Acidity and Alkalinity, SPECIFIC TESTS/Water Determination , Method I, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/Labeling, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Lauric Acid RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Sodium Decanoyl Sarcosinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Sodium Lauroyl Sarcosinate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Sodium Myristoyl Sarcosinate RS Hong Wang

Revision SODIUM MONOFLUOROPHOSPHATE PF 43(4) Pg. ONLINE

IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Limit of Fluoride Ion, ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Sodium Acetate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Sodium Monofluorophosphate RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Sodium Sulfate RS Michael Chang

Revision SODIUM THIOSULFATE INJECTION PF 43(2) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/Procedure, ASSAY/Procedure, IMPURITIES/Limit of Sulfate and Sulfite, IMPURITIES/Limit of Sulfide, SPECIFIC TESTS/Bacterial Endotoxins Test , SPECIFIC TESTS/pH , SPECIFIC TESTS/Sterility Tests , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Sodium Sulfate Anhydrous RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Sodium Sulfide RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Sodium Thiosulfate RS Donald Min

Revision SPIRONOLACTONE PF 42(1) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B. Ultraviolet Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Ordinary Impurities , IMPURITIES/Organic Impurities, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Spironolactone Related Compound B RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Spironolactone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Spironolactone Related Compound D RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Spironolactone Epimer Mixture RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Spironolactone Related Compound I RS Donald Min

Revision ABSORBABLE SURGICAL SUTURE PF 43(4) Pg. ONLINE SPECIFIC TESTS/Sutures-Diameter , ADDITIONAL REQUIREMENTS/Labeling Desmond HuntRevision NONABSORBABLE SURGICAL SUTURE PF 43(4) Pg. ONLINE DEFINITION/Introduction, SPECIFIC TESTS/Sutures-Diameter Desmond Hunt

New TACROLIMUS OINTMENT PF 43(3) Pg. ONLINE

Title, DEFINITION/Introduction, IDENTIFICATION/A., IDENTIFICATION/B., ASSAY/Procedure, PERFORMANCE TESTS/Minimum Fill , IMPURITIES/Organic Impurities, SPECIFIC TESTS/Microbial Enumeration Tests and Tests for Specified Microorganisms , ADDITIONAL REQUIREMENTS/Packaging and Storage, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Tacrolimus RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Tacrolimus Related Compound A RS Praveen Pabba

Revision TERAZOSIN TABLETS PF 43(2) Pg. ONLINE

DEFINITION/Introduction, IDENTIFICATION/Ultraviolet Absorption , ASSAY/Procedure, Identification A, Assay and Dissolution, PERFORMANCE TESTS/Dissolution , IMPURITIES/Organic Impurities Donald Min

Revision TESTOSTERONE PF 41(4) Pg. ONLINE

IDENTIFICATION/Infrared Absorption , IDENTIFICATION/B. Ultraviolet Absorption , IDENTIFICATION/B., ASSAY/Procedure, IMPURITIES/Organic Impurities, SPECIFIC TESTS/Melting Range or Temperature , ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Exemestane Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Testosterone Related Compound A RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Testosterone Related Compound C RS, ADDITIONAL REQUIREMENTS/USP Reference Standards /USP Testosterone Related Compound I RS Ren-Hwa Yeh

Revision TESTOSTERONE ENANTHATE PF 43(3) Pg. ONLINE

IDENTIFICATION/A. Infrared Absorption , IDENTIFICATION/B. Ultraviolet Absorption , IDENTIFICATION/B., IDENTIFICATION/C., ASSAY/Procedure, IMPURITIES/Ordinary Impurities , IMPURITIES/Org